Industrialized countries usually have a high price of pharmaceuticals, so generic pharmaceuticals are used most frequently. Sales of generic drugs in Canada, the US, the UK, and Denmark is more than 40% of the total pharmaceutical sales (King and Kanvos, 2002). Patients are more likely to choose generic drugs as long as they get reimbursed for newer patented drugs whereas their savings are spent in making choices among the generic drugs. However, generic drugs have been heavily criticized for their substandard manufacturing and poor quality. Apart from the fact that they are not rigorously tested, problem also relates to poor compliance of the manufacturers of generics with the practice guidelines.
The cost of general drugs is typically lesser than the branded drugs by 30% to 60% (Lewek and Kardas, 2010). Patients on generic drugs have increased tendency to continue therapy compared to patients who take branded drugs. Generic drugs are spared the expensive clinical trials that are a prerequisite for branded drugs to be approved which makes the quality and safety of general drugs questionable.
Some legal loopholes which delayed the approval of generic drugs have been closed by The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (FDA, 2011). This is evident from the fact that the act does not allow for more than a 30-month stay of generic approval when a generic company is sued by an innovator company with respect to patent issues. A stay is delay in the approval of the generic drug which happens when a patent infringement lawsuit is filed by a branded drug company. The purpose of this delay is to allow time to solve issues regarding the infringement of a drug patent by a generic company. The generic drug is not approved by the FDA during the stay. 30-month stays is the limit established in line with the Federal Trade Commission (FTC) recommendations (FDA,